U.S. patent application number 16/902712 was filed with the patent office on 2020-12-24 for air hammock for a prosthetic.
The applicant listed for this patent is James Jay Martin. Invention is credited to James Jay Martin.
Application Number | 20200397602 16/902712 |
Document ID | / |
Family ID | 1000004904830 |
Filed Date | 2020-12-24 |
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United States Patent
Application |
20200397602 |
Kind Code |
A1 |
Martin; James Jay |
December 24, 2020 |
AIR HAMMOCK FOR A PROSTHETIC
Abstract
The invention is an air hammock for a prosthetic with dynamic
conformity to better match to the underlying limb shape in
real-time through a combination of structural support members with
modularly adjustable compliant members thereby creating an air
hammock for a prosthetic by suspending the limb within the socket
without pressure on the bottom of the residual limb.
Inventors: |
Martin; James Jay; (Oklahoma
City, OK) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Martin; James Jay |
Oklahoma City |
OK |
US |
|
|
Family ID: |
1000004904830 |
Appl. No.: |
16/902712 |
Filed: |
June 16, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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62863122 |
Jun 18, 2019 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/80 20130101; A61F
2/7843 20130101 |
International
Class: |
A61F 2/78 20060101
A61F002/78; A61F 2/80 20060101 A61F002/80 |
Claims
1. A transfemoral prosthetic interface having a circumference for a
residual limb having a circumference and a distal end comprising: a
socket having a first side and a second side; a floating strut
between said first side of said socket and said second side wherein
said floating strut does not touch said first side or said second
side of said socket; a lacing system connected to said first side
and said second side of said socket and adapted to hold said
floating strut between said first side and said second said of said
socket; and wherein said socket, said floating strut, and said
lacing system form a circumference are adapted to support said
residual limb around said circumference of said residual limb
without putting pressure on said distal end of said limb.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority to U.S. Provisional
Patent Application Ser. No. 62/863,122 filed Jun. 18, 2019 and
incorporated by reference herein.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The present invention relates generally to a limb prosthesis
or orthosis for amputees or orthotic users. More particularly, the
present invention is a new and improved socket that provides
dynamic conformity to better match to the underlying limb shape in
real-time through a combination of structural support members with
modularly adjustable compliant members thereby creating an air
hammock for a prosthetic by suspending the limb within the socket.
It is further contemplated to provide a computer controlled
non-back drivable gear mechanism to adjust the circumference of the
prosthetic interface to match as desired the circumference of the
residual limb.
2. Background of the Invention
[0003] It is estimated that by the year 2050, the number of
amputees will double to over 3.6 Million. American population
health concerns are strongly correlated to the weight and age of
the individual. The American population and its health patterns
show an increase in all high-risk areas as related to dysvascular
disease, a leading cause of both stroke and amputation. In the
United States, 97% of dysvascular related amputations involve the
lower limb. The aging baby-boomer population is just entering the
age where vascular insufficiencies tend to drastically increase,
thus, a large influx of stroke patients and amputee patients will
be entering the U.S. market alone in the coming few years.
[0004] Likewise, there exists over 30,000,000 amputees in
developing nations, where less than 5% will have access to
well-fitting prosthetics in their lifetime. Three main causes of
such a dramatically underserved amputee population in developing
nations are conventional prosthetics are relatively expensive to
fabricate and fit; there is a lack of expensive equipment needed to
fabricate conventional prosthetics; and there is a lack of trained
and skilled practitioners who are able to fit them.
[0005] The prosthetics market has advanced significantly in recent
years now utilizing many new advanced components such as computer
controlled knees and feet. However, the socket interfaces are
minimally different from what was being used 20 to 30 years ago. In
fact, many of the socket interfaces that are still considered
state-of-the-art were originally developed between the 1960's and
1990's, with only minor advancements in materials and suspension
methods since then. The core socket interface designs have gone
largely unchanged.
[0006] Conventionally used prosthetic interfaces remain as an
anatomically contoured socket in which the residual limb fits
within. This socket may be specifically tailored to the residual
limb's size and shape, but it largely remains as a static size and
shape.
[0007] While some flexible materials may be incorporated, their
flexibility is typically no more than minor amounts of give at
their edges, and not true accommodation for the dynamic nature of
the underlying body in which they are fit. There are numerous
prosthetic and orthotic companies that provide components for
conventional interface designs ranging from various embodiments of
gel liners and suspension aids for prosthetics users. In each of
these, the core interface approaches used are antiquated and in
desperate need of more advanced methods of how to fit prosthetic
devices.
[0008] In the field of clinical prosthetics, the conventional
prosthetic sockets have historically used static rigid materials
that are anatomically contoured to match the underlying limb shape
typically using carbon fiber or other laminates, thermoplastic
shells of various stiffnesses each of which has a shape,
contouring, and size, which is largely or wholly set. Each of the
prior art embodiments of prosthetic sockets utilizes largely
un-conforming elements that surround and encapsulate the underlying
limb to create a structure to support the user's limb within the
socket. The shape of such structural elements is specifically
anatomically contoured to the underlying limb shape in order to
provide an anatomical match for the user.
[0009] Conventional teachings suggests that the residual limb needs
to be encapsulated in rigid or semi-rigid structure to support the
user through a hydrostatic or specific pressure loading method as
is conventionally used in the field of clinical prosthetics.
However, the dynamic limb anatomy changes frequently (daily and/or
over a period of time) resulting in the dynamic limb shape no
longer matching to the static socket shape. Certain attempts have
been made in creating adjusting sockets, although the prior art
still utilizes the same encapsulated, rigid, static methods to
accomplish the same, though with certain areas of the socket being
adjustable.
[0010] For instance, the Revo-Fit socket system uses adjustable
rigid panels that can press inward or outward, though the overall
socket design remains rigid and unconforming. The CJ Sail socket
system uses a compliant panel attached to a rigid static socket
frame. This design, while more conforming than others, requires a
large portion of the limb to rest against a static, rigid socket
frame. Additionally, the single compliant member of that design
fails to fully conform along the length of the limb, or conform
around the circumferential shape of the limb--since the human limb
shape changes in contouring with volume gain or loss along both the
length and circumference of the limb.
[0011] Through using compliant dynamic socket materials that
encapsulate the limb, the limb muscles no longer hit a rigid wall,
and therefore have the ability to more effectively contract and
hypertrophy. In conventional rigid sockets, the limb muscles may
hit a rigid socket wall, preventing them from contracting, and
hence the limb muscles often atrophy over time. As the limb muscles
are now allowed to contract more effectively because of the use of
the compliant dynamic socket materials, the muscles therefore
exhibit greater blood flow and circulation, and hence greater limb
health.
[0012] The current state-of-the-art fails to truly accommodate for
limb volume changes, has narrow transitions from high force to no
force resulting in rubbing and discomfort, and creates a volatile
skin environment that is hot and sweaty. In recent years there have
been a few attempts at improving lower extremity socket interface
design, and overcome some of the outstanding issues surrounding
them.
[0013] It is, therefore, desirable to provide a new and improved
socket that provides additional areas of the limb that can be
contained and controlled through more dynamic and compliant
materials, versus rigid or semi-rigid support members, where the
limb can be suspended within the socket with predominantly
compliant dynamic materials, which more effectively contour to the
underlying limb shape, and results in a more comfortable socket
where the prior art is deficient. The above discussed limitations
in the prior art are not exhaustive. The current invention provides
an inexpensive, time saving, more reliable apparatus and method of
using the same where the prior art fails.
SUMMARY OF THE INVENTION
[0014] In view of the foregoing disadvantages inherent in the known
types of prosthetic interface design, the present invention
provides a new and improved, apparatus, system, and method of
providing control and comfort within a prosthetic device in a more
efficient and effective manner. As such, the general purpose of the
present invention, which will be described subsequently in greater
detail, is to provide a new and improved apparatus, system, and
method, which has all the advantages of the prior art devices and
none of the disadvantages
[0015] In a preferred embodiment, the invention may comprise an air
hammock for a prosthetic with dynamic conformity to better match to
the underlying limb shape in real-time through a combination of
structural support members with modularly adjustable compliant
members thereby creating an air hammock for a prosthetic by
suspending the limb within the socket without pressure on the
bottom of the residual limb.
[0016] In this respect, before explaining at least one embodiment
of the invention in detail, it is to be understood that the
invention is not limited in this application to the details of
construction and to the arrangement of the components set forth in
the following description or illustrated in the drawings. The
invention is capable of other embodiments and of being practiced
and carried out in various ways. Also, it is to be understood that
the phraseology and terminology employed herein are for the purpose
of description and should not be regarded as limiting. As such,
those skilled in the art will appreciate that the conception, upon
which this disclosure is based, may readily be utilized as a basis
for the designing of other structures, methods and systems for
carrying out the several purposes of the present invention. It is
important, therefore that the claims be regarded as including such
equivalent constructions insofar as they do not depart from the
spirit and scope of the present invention.
[0017] Accordingly, titles, headings, chapters name,
classifications and overall segmentation of the application in
general should not be construed as limiting. Such are provided for
overall readability and not necessarily as literally defining text
or material associated therewith.
[0018] Further, the purpose of the foregoing abstract is to enable
the U.S. Patent and Trademark Office and the public generally, and
especially the scientist, engineers and practitioners in the art
who are not familiar with patent or legal terms or phraseology, to
determine quickly from a cursory inspection the nature and essence
of the technical disclosure of the application. The abstract is
neither intended to define the invention of the application, which
is measured by the claims, nor is it intended to be limiting as to
the scope of the invention in any way.
[0019] It is, therefore, an object of the present invention to
provide a new and improved dynamic prosthetic interface for a
better match to the underlying limb shape in real-time through a
combination of structural support members with modularly adjustable
compliant members thereby creating an air hammock for a prosthetic
by suspending the limb within the socket.
[0020] It is a further object of the present invention to provide a
prosthetic interface that may utilize, flexible bands and or cross
connectors that may span between structural members and floating or
anchored struts to circumferentially surround the limb, and provide
support.
[0021] Another further object of the present invention is to
provide a prosthetic interface with an even greater surface area of
the residual limb that may be supported by materials of greater
conformity to provide even greater comfort.
[0022] Even another further object of the present invention is to
provide a prosthetic interface with an even greater surface area of
the residual limb that may be supported by materials of greater
conformity to provide even greater comfort that is simpler and more
consistent to which is user adjustable.
[0023] Still another further object of the present invention is to
provide a prosthetic interface that matches a user's needs,
including through using materials of various stiffnesses,
flexibility, stretch, texture, more breathable, and
containment.
[0024] It is also another further object to provide a computer
controlled non-back drivable gear mechanism to adjust the
circumference of the prosthetic interface to match as desired the
circumference of the residual limb.
[0025] It is a further object of the present invention to provide a
prosthetic interface that is lower profile under clothing and
lighter in weight.
[0026] It is a further object of the present invention to provide a
prosthetic interface that is modular and repairable.
[0027] It is a further object of the present invention to provide a
prosthetic interface that can be fabricated less expensively and
quicker.
[0028] Yet another further object of the present invention is to
provide a prosthetic interface wherein additional areas of the limb
can be contained and controlled through more dynamic and compliant
materials, versus rigid or semi-rigid support members.
[0029] It is a further object of the present invention to provide a
prosthetic interface that truly accommodates for volume and shape
changes of the dynamic underlying body wherein the limb can be
suspended within the socket with predominantly compliant dynamic
materials, which more effectively contour to the underlying limb
shape, and result in a more comfortable socket.
[0030] It is still a further object of the present invention to
provide a prosthetic interface that does not encapsulate the limb
in the same manner as conventional designs.
[0031] It is still yet a further object of the present invention to
provide a prosthetic interface that captures the lost biomechanical
and neuromuscular connection between the limb and the user.
[0032] It is also is a further object of the present invention to
provide a prosthetic interface to better control underlying bone
position within the socket.
[0033] Another object of the present invention is to provide a new
and improved system, which provides some of the advantages of the
prior art, while simultaneously overcoming some of the
disadvantages normally associated therewith.
[0034] These together with other objects of the invention, along
with the various features of novelty that characterize the
invention, are pointed out with particularity in the claims annexed
to and forming a part of this disclosure. For a better
understanding of the invention, its operating advantages and the
specific objects attained by its uses, reference would be had to
the accompanying drawings and descriptive matter in which there are
illustrated preferred embodiments of the invention.
BRIEF DESCRIPTION OF THE PICTORIAL ILLUSTRATIONS, GRAPHS, DRAWINGS,
AND APPENDICES
[0035] The invention will be better understood and objects other
than those set forth above will become apparent when consideration
is given to the following detailed description thereof. Such
description makes reference to the annexed pictorial illustrations,
graphs, drawings, and appendices.
[0036] FIG. 1 generally illustrates an embodiment in accordance
with the current invention.
[0037] FIG. 2 generally illustrates an embodiment in accordance
with the current invention.
[0038] FIG. 3 generally illustrates an embodiment in accordance
with the current invention.
[0039] FIG. 4 generally illustrates an embodiment in accordance
with the current invention.
[0040] FIG. 5 generally illustrates an embodiment in accordance
with the current invention.
[0041] FIG. 6 generally illustrates an embodiment in accordance
with the current invention.
[0042] FIG. 7 generally illustrates an embodiment in accordance
with the current invention.
[0043] FIG. 8 generally illustrates an embodiment in accordance
with the current invention.
[0044] FIG. 9 generally illustrates an embodiment in accordance
with the current invention.
[0045] FIG. 10 generally illustrates an embodiment in accordance
with the current invention.
[0046] FIG. 11 generally illustrates an embodiment in accordance
with the current invention.
[0047] FIG. 12 generally illustrates an embodiment in accordance
with the current invention.
[0048] FIG. 13 generally illustrates an embodiment in accordance
with the current invention.
[0049] FIG. 14 generally illustrates an embodiment in accordance
with the current invention.
[0050] FIG. 15 generally illustrates an embodiment in accordance
with the current invention.
[0051] FIG. 16 generally illustrates an embodiment in accordance
with the current invention.
[0052] FIG. 17 generally illustrates an embodiment in accordance
with the current invention.
[0053] FIG. 18 generally illustrates an embodiment in accordance
with the current invention.
[0054] FIG. 19 generally illustrates an embodiment in accordance
with the current invention.
[0055] FIG. 20 generally illustrates an embodiment in accordance
with the current invention.
[0056] FIG. 21 generally illustrates an embodiment in accordance
with the current invention.
[0057] FIG. 22 generally illustrates an embodiment in accordance
with the current invention.
[0058] FIG. 23 generally illustrates an embodiment in accordance
with the current invention.
[0059] FIG. 24 generally illustrates an embodiment in accordance
with the current invention.
[0060] FIG. 25 generally illustrates an embodiment in accordance
with the current invention.
[0061] FIG. 26 generally illustrates an embodiment in accordance
with the current invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0062] Referring now to the drawings, wherein like reference
numerals designate corresponding structure throughout the views,
and referring in particular to the figures, numeral 10 generally
refers to a new and improved compliant based transfemoral level
prosthetic socket apparatus, assembly, and or system, hereinafter
referred to generally and collectively as invention 10.
[0063] Of note, invention 10 may be generally shown by example in a
configuration for an individual missing a right or left leg or
portion thereof at a knee disarticulation or transfemoral level. It
is understood that such configuration is for example purposes only
and that such should not be considered limiting and a left or right
side configuration is also considered. It is further understood
that invention 10 may be used where the level of amputation may
dictate a different configuration than transfemoral or knee
disarticulation level, such as but not limited to transtibial,
transradial, transhumeral, or other levels either prosthetically,
orthotically, or with exoskeletal robotics, all of which may be
considered as human/machine connectivity.
[0064] The terms should not be considered limiting the invention
nor the general shape and configuration depicted in the drawings.
Invention 10 may encompass many embodiments, as generally
illustrated in the various figures, and should not be considered
limiting where any particular figure depicts one embodiment of
invention 10, as there are various elements, embodiments, and user
specific requirements. Likewise, the number or placement of
anchored or floating struts should not be considered limiting, as
any strut may be anchored or floating, and their position for
example may use floating struts on the anterior and anchored on the
posterior aspect of the socket as well for example.
[0065] In a preferred construction, there may be a distal
attachment area or structure for mounting other prosthetic
components to, such as but not limited to knees, feet, stubbers,
connectors, or other conventionally used components which are used
distal to a socket apparatus. The particular attachment means may
be any conventionally used means, including plates, screws, gunk,
and others.
[0066] FIG. 1 generally illustrates a preferred embodiment for a
socket 25 with a first side 20 and a second side 30, which may be
two posterior vertical supporting members, and or floating struts,
with a middle floating strut 40 in between to encapsulate the limb
with modular dynamic adjustable members 50 and 60. This
illustration is shown with conformable modular dynamic members 50
and 60 that help circumferentially contain the limb and do not put
any pressure on the residual limb distal end. While various methods
of adjustability may be used, this illustration exhibits the use of
a lacing system 70 with a ratchet and ladder strap 80 to tighten
the two floating posterior struts together.
[0067] FIG. 2 generally illustrates a preferred embodiment using
one posterior strut 90, instead of two or three, to encapsulate the
limb. This illustration is shown with conformable modular dynamic
members 100 and 110 that help circumferentially contain the limb,
and can also include adjustability as desired.
[0068] In each of the FIGS. 1 and 2 configurations, the limb is
encapsulated with modular dynamic members attached to anchored
and/or floating struts to circumferentially support the limb and
match to the user's limb shape, and may have adjustable means. The
circumferential supporting modular dynamic members may be
dynamically flexible enough to contour to the limb shape and
generally wrap around the limb shape, while the vertical supporting
members may have enough structural integrity to help post and
support the limb tissue such that it prevents the circumferential
members from roping into the limb tissue.
[0069] Through using one, two, three, or more vertical members, or
struts, the limb remains supported while the modular dynamic
circumferential members flexes to allow for circumferential
contouring of the socket about the limb shape. In such
illustrations, the distal receptacle and vertical struts are
floating, and suspended from the anterior support structure via the
circumferential components. It is understood that both the vertical
and or the circumferential members may have varying degrees of
flexibility, conformity, or rigidity to accomplish the goal of
contouring to the limb's shape.
[0070] Any such members, including the circumferential members may
be fabricated of various types of materials including
thermoplastics, textiles, webbing, or other such materials that
exhibit such conformability characteristics. It is understood that
in this embodiment and others illustrate that the terms webbing and
others should not be considering limiting, and may include a
variety of materials that may exhibit ultra-conforming
characteristics, and may include materials such as nylon webbing,
polyester webbing, polypropylene webbing, nomax webbing, kevlar
webbing, or a variety of other materials used in similar
applications such as lacing, wires, or others.
[0071] Likewise, the descriptive term webbing may utilize various
embodiments of lacing, including cables, strings, bands, or other
materials used in lacing applications, all of which shall be
considered one and the same, as each of the descriptive of the
materials are conforming, may be placed through guides, routed in
various patterns, and or used to tighten an object around the body,
similar to clothing or shoe applications.
[0072] It is contemplated that any such webbings or lacing methods
may provide a self-leveling means of accommodating for high force
areas within the socket, similar to how a sneaker's laces may
self-level in tightness between the various laces, assuming a
low-friction lacing system. In such systems, when laces are pulled
tight, the `pulley system` of the laces causes any certain tight
lace to loosen via the adjoining laces tightening to equalize
forces between laces. It is contemplated that a webbing system may
be combined with a lacing system specifically in order to allow for
a greater amount of self-leveling in tightness across the limb, as
generally illustrated in FIGS. 11 and 12.
[0073] FIG. 3 and FIG. 4 illustrate similar socket embodiments as
FIGS. 1 and 2 although integrates the distal receptacle 120 and or
vertical support member strut assembly 130 into a posterior distal
aspect of a frame structure 140 via at least one mounting point
150. In such an embodiment, the distal aspect of the strut may be
mounted, though still allow for the proximal end to dynamically
adjust in an anterior/posterior, and even possibly medial/lateral
aspects, as the connection point may exhibit a certain level of
living hinge characteristics, or other similar means to accomplish
the same flexibility yet stability. In such an example, the use of
a distal receptacle may be integrated to support the distal aspect
of the limb, or the limb may rest into or within the distal aspect
of the frame mount, which may be contoured to generally match the
distal aspect of the limb shape.
[0074] FIGS. 5 and 6 illustrate a distal receptacle 160, which may
be mounted to the posterior vertical support(s) mounting location
to a frame 170, as well as the anterior rigid support member
directly or via a suspended flexible support member 180, which may
be mounted to an anterior rigid support member 190. Flexible
vertical members may be suspended from the inside of the anterior
support structure member more proximally, and allowing their distal
aspect to hang within the structure. In such an example the distal
receptacle 160 may be mounted to the anterior flexible support
members 180, which may be mounted to the anterior support structure
190, thereby allowing the distal receptacle 160 to be suspended by
both the anterior and posterior aspect of the socket configuration,
and provide support of the limb but through compliant materials,
versus the end of the limb resting into a rigid structural element.
In one such embodiment, the posterior aspect of the receptacle may
be mounted to the distal aspect of the posterior strut and/or
posterior frame section assembly, while the anterior aspect of it
may hang from the anterior vertical support members, and therefore
allowing it to float within a main support structure 200 like a
hammock. In such an example, as weight of the limb is pressed into
the distal receptacle, it may promote the receptacle to pull away
from the anterior main support structure 200, thereby preventing
pressure against a rigid structure during weight bearing.
[0075] FIGS. 7 and 8 illustrate similar socket embodiments as FIGS.
1 and 2 although may integrate a more compliant webbing 210 in
place of thermoplastic circumferential connectors. Through using a
more compliant material such as webbing, the socket sub-components
may more effectively contour to the limb shape. It is anticipated
that various materials may be used here, and such description
should not be considered limiting. It is contemplated that through
using a more compliant material such as a webbing that various
lacing configurations may be used to support the limb in various
ways. It is understood that the term lacing is generally used in
this context to describe the routing, mounting, adjustability,
security, and/or positioning of such a webbing or the like. For
example, similar to how laces are used in a shoe, various
configurations may be used on how the laces are routed through the
eyelets, how they are attached, where they are attached, how they
are secured, and other such considerations.
[0076] FIGS. 9, 10, 11, and 12 illustrate various configuration
embodiments where various numbers of such webbing material(s) 220
may be wrapped around the limb, such as one, or many.
[0077] Each of the following cross section views of the socket may
as well utilize various numbers of webbings around the limb,
including one webbing wrapped around the limb, or multiple webbings
wrapped around the limb. In a preferred embodiment, various numbers
of webbings wrapped around the limb may be advantageous as it may
allow for more specific adjustability to the limb anatomy, discrete
individual adjustments to be made at various limb levels, or a
unique combination of lacing patterns to more effectively capture
and control the limb tissue.
[0078] In the various FIGS. 13 through 20 configurations, the
modularity of such webbing may be routed in various patterns,
anchored in various methods or positions, and integrate various
adjustability or locking mechanisms wherein directional loops 230,
attachment and or anchor point 240, buckle and or adjustment
mechanism ratchet 255, lace and or web guide 250, webbing 260,
anchored or floating strut and or frame 270, suspended flexible
member 280, and insert connector 290 are generally depicted in
figurative format
[0079] The illustrations simply suggest various possible
embodiments to accomplish the same. In a preferred embodiment, the
proposed anterior struts (proximal on the illustrations) may be
anchored supports while the posterior strut (distal on the
illustration) may be floating or distally mounted or anchored yet
conforming and/or adjustable to the limb. In such examples, and in
others, any such strut may be floating or anchored in the various
configurations.
[0080] Likewise, while two anterior struts are shown, and one
posterior strut is shown, it is contemplated that various numbers
of struts may be used, including one anterior strut, two posterior
struts, or other numbers. Similarly, the term strut should not be
considering limiting, and generally refers to an area where
webbings or the like may be mounted or supported. The strut may be
a modular component, which can be assembled onto the socket in
various positions, angles, contouring's, or lengths, and allow the
socket assembly to mount thereto, or the strut may be a custom
molded form based on the limb anatomy.
[0081] The illustration of two anterior struts in a preferred
embodiment may enable a simplified design for durability,
minimization, and ease of assembly. For comparison, one anterior
strut is contemplated though may require additional complexities
for durability, rigidity, and assembly. Using two or more struts on
the posterior side are contemplated but may add components and
complexities compared to a single posterior strut assembly. If one
anterior strut were used, and two posterior struts, for example,
the webbing may be able to more effectively contour under the
tibial condyles to help support the limb, though this is not a
preferred embodiment. Regardless of the type of strut, the modular
assembly of such a system may be accomplished by capturing a
digital or physical impression of the limb and assembling the
modular socket components over such impression, or may be built
over the limb directly. By way of example, a cast of the limb may
be captured using fiberglass wrap, or similar materials, and may
include an alienable component within to attach to other prosthetic
components. The cast's trim lines may be cut to preference, and
holes drilled for mounting the modular socket components thereto.
The cast shape may functionally become the anchored struts. The
modular socket components may be assembled to match the user's limb
shape, and adjustments may be made on the limb. Mounting modularly
connected floating or anchored struts may be accomplished by
physically connecting a portion of such strut to a portion of the
cast frame section, and which may be connected using materials or
means which provide a sort of living hinge at the connection point,
allowing the connected strut to be controlled in where and how it
may move relative to the frame assembly.
[0082] FIG. 14 illustrates an embodiment where the webbing may be
mounted to one anchored strut, wrapped around the limb, through a
guide connecting to a possible adjoining floating or anchored
strut, and through an adjustable mechanism, which may be attached
to webbing connecting to yet another strut. In such an example, a
single or multiple webbings may be used to wrap circumferentially
around the limb top to bottom for instance, and may or may not
include an adjustable mechanism to adjust the length of the
webbing. It is contemplated that the webbing may or may not
directly interact with or be physically connected to the
illustrated middle strut, but in a preferred embodiment, it may be
either physical connected or may use a guide to virtually connect
it to the strut, thereby allowing for it to hence control the
position, compression, or other dynamics of such a strut with
respect to the underlying limb. It is contemplated that interaction
or connectivity to such a strut enables for the span of the webbing
to be controlled around the limb tissue, by the strut posting the
limb tissue such that the webbing does not rope into the limb
tissue, and provide additional bony or anatomical control of the
limb. Residual limb circumference 245 is generally to illustrate
the prosthetic interface circumference 235. The depictions are for
general purposes and not intended to show actual fit and or
circumferences.
[0083] It is contemplated that a floating strut may as well not
connect to any anchored portion of the system, and may simply be
attached to the webbing alone such that it helps post the limb
tissue as the webbing wraps around the body. In such an example,
there may be one or various webbing members, typically oriented
above and below each other as they each wrap around the limb from
top to bottom for example. A true floating strut may be attached to
each of the various webbing members, for instance vertically,
connecting two or more webbing members, and may be a modular
element to provide added pressure within a certain area of the
socket.
[0084] FIG. 15 illustrates an embodiment where multiple
circumferential webbings may be mounted to anchored struts for
instance, around a portion of the limb, and through an adjustor
mechanism on an adjoining strut. In any such example, the adjuster
mechanism may use any method used to secure the webbing within the
system, and prevent it from loosening. This may include, but not
limited to, backpack-type buckles, ratchets of various types,
Velcro, and others. It is contemplated that a myriad of various
types of such adjustor mechanisms may be used to accomplish the
same.
[0085] FIG. 16 illustrates an embodiment where at least one webbing
may be mounted to a strut, routed through a direction loop on an
adjoining strut, and back through an adjustor on the other strut.
In such an example, the added directional loop provides mechanical
advantage for pulling the webbing tighter on the limb.
[0086] FIG. 17 illustrates an embodiment where at least one webbing
may be mounted to a strut, routed through a directional loop on an
adjoining strut, back through another directional loop, and then
through an adjustor, in order to provide additional mechanical
advantage. It is contemplated that any number of directional loops
may be included to provide additional mechanical advantage.
[0087] FIG. 18 illustrates an embodiment where the webbing may be
floating, and not directly hard-connected to the struts as in other
illustrations, and may be routed through at least one directional
loop, and then may be routed through an adjustor mechanism. In such
an example, by not hard-connecting the webbing loop to the struts,
and allowing it to instead float within the socket, as the webbing
is tightened through the adjustor mechanism, it may both pull a
connected floating strut toward the other anchored struts and
simultaneously may pull the limb back toward the connected floating
strut. In the example of a below knee prosthetic socket, the
posterior strut (distal strut in the illustration) may be connected
or mounted at its distal aspect to the frame, which may allow its
proximal end to bend forward as the socket is tightened, while
maintaining its distal aspect pulled back toward the posterior
distal aspect of the frame. As the webbing is tightened, the
residual limb may be pulled back posteriorly at its distal aspect
via the adjustable webbing, while the proximal end of the limb may
be pressed forward toward the anterior anchored struts. This may be
biomechanically advantageous, as the sensitive distal aspect of the
limb may be supported through a more compliant webbing material
versus hitting a rigid structure.
[0088] In order to help simplify the integration of various
webbings wrapping around the limb, an additional insert may be
used, which may connect to the webbings along the anterior aspect
of the limb, which may help hold the various webbings in
orientation with respect to each other and/or the anterior struts.
This may be made of another textile material, mesh, webbing, foam,
Velcro, plastic, laminate, or other materials, which may generally
help to connect the various webbings together proximal to distal.
This insert may as well be partially connected to the struts on its
proximal end to help encourage the anterior aspect of the webbing
to provide more posting support distally versus proximally. In
addition, the insert may include suspension mechanisms incorporated
within to help hold the prosthetic in place. For instance, this
insert may include a unidirectional friction element, which may
help suspend the prosthetic on the limb, through the insert's
inherence compliance and conformity to the limb shape. Since the
insert, along with the attached webbing, may be so conforming to
the limb shape it may provide greater capture of the intimate
contouring of the limb, and therefore, allow such friction, or
other suspension elements, to hold onto the limb/liner with greater
effectiveness.
[0089] Through integrating the floating webbing within the socket
to support the limb and post it away from the struts, the limb may
predominantly be supported by compliant dynamic materials versus
rigid structure more so than any other socket available. Likewise,
the angles of the various layers of webbing as they route though
the directional loops may encourage more tissue containment, as the
overlapping spans of webbing at different angles may provide
greater coverage over the limb and may prevent limb tissue from
protruding through--as illustrated in FIG. 19, as viewed from
looking into the socket from above; and FIG. 20, as viewed from
looking at the side of the socket. In each illustration, the
direction and angle of each layer of webbing is such that the
underlying layer crosses at an angle compared to the overlying
layer such that it may help cover the span in between the outer
webbing layers. This may provide additional tissue containment.
[0090] On the posterior side of the socket, a flexible member 300
may extend proximally up from the posterior strut, and extend past
the patellar tendon level in height (which is typically associated
with the level of posterior brim of a below knee socket). The
flexible member may provide additional comfort during knee flexion,
by allowing the posterior brim of the socket to have a larger
radius in shape versus a trimmed edge of a socket material cutting
into the fold in the knee.
[0091] It is contemplated that various forms of adjustor mechanisms
may be used to help tighten the webbings around the limb, including
hand-tightening, or mechanical or electro-mechanical tightening. In
a preferred embodiment, the unique modularity of such technology
may allow for any form of tightening to occur, based on end-users'
needs. However, in order to provide a more elegant user experience,
managing the ends of the webbing within an adjustor mechanism may
be advantageous, versus hand-tightening by pulling on a tail end of
the webbing.
[0092] FIGS. 21 and 22 illustrate one embodiment of an adjuster
mechanism. which may help manage the webbing. In such an example
webbing sections 310 may be connected to at least one shaft 320.
The other end of such webbing may loop around the limb similar to
any of the FIGS. 13 through 20 examples. Connected to the shafts
320 may be a gear mechanism 330, which may enable the user to
tighten the webbing around the shafts 320 with a dial or other such
ergonomic method 340, and which may use a worm gear 350 or other
such gearing methods to transfer the rotation of the shafts 320
perpendicular to match the dial 340.
[0093] In a preferred embodiment, such mechanism may be low
profile, durable, simple to use, ergonomic, non-backdriveable,
among other characteristics. While various methods may be used to
accomplish such characteristics, the illustration and explanation
should not be considered limiting but is used for example and ease
of understanding.
[0094] Through using a non-backdrivable gear mechanism 345, such as
but not limited to a worm gear 350, a simple positive-locking
positioning of the webbing may be achieved without the need of
other locking mechanisms. An ergonomic dial may be used in-line
with the worm gear for ease of adjustability. And shafts may be
integrated with the gear mechanisms to roll up the webbing. Such an
assembly may be mounted along the length of one of the struts.
[0095] As is illustrated in FIG. 22, the further integration of
additional gears and/or motor, sensor(s), and battery, altogether
motor assembly 360 may provide a self-adjusting means of tightening
the socket. In such an example, motor assembly 360 may be
controlled through a microprocessor or the like along with at least
one sensor to help control the device including but not limited to
time sensor, motor position sensor, motor torque sensor,
accelerometer or the like, force sensor, or other such sensors.
Upon the tightening of the webbing through the motor and
controller, the socket fit may be tightened, and vice versa with
loosening the socket.
[0096] FIG. 23 illustrates a perspective view as represented in
FIGS. 21 and 22, of what such a gear mechanism 345 may resemble. In
such an example, dial may be connected to worm gear, which may
interface with gears connected to shafts, upon which such webbing
may role up on as the dial is turned. Such a unit may be mounted at
various locations on a socket, although in a preferred embodiment,
upon a strut, such as the posterior floating or connected strut of
a below knee socket for example.
[0097] As illustrated in FIGS. 24 and 25, user initiated changes to
the motor position may be used, or autonomous control mechanisms
may be used. User initiated means may include a user inputting
directions to smart phone or push button to direct the motor
assembly movement or position. Autonomous control mechanisms may
include sensor input to direct the motor assembly movement or
position.
[0098] In a preferred embodiment, the user may program set for
autonomous control of the device a maximum socket tightness and a
minimum socket tightness, may set activity related socket
tightnesses, or other such means of controlling the socket's
webbing position. When a user dons the socket, autonomous or a user
initiated input may begin the tightening of the socket to a pre-set
tightness positioning or pre-set user preferred force positioning
of the webbing, and vice versa for doffing the socket. Sensor input
may help determine the user's activities such as resting, walking,
running, or others, and may be used to adjust the socket tightness
or positioning as it relates to the user's activities.
[0099] For example, when the user is in a resting position the
socket may loosen slightly, whereas when the user is walking or
running the socket tightness may be greater. The socket may as well
provide for cyclical tightening and loosening throughout the day to
help promote blood flow to the limb or other reasons such as
re-assessing torque values on a motor to correspond to proper
tightening of the socket to the existing limb shape. As the limb
may change in volume throughout the day, the webbing may as well
tighten to accommodate for a reduction in limb volume for instance.
It may also have a self-learning algorithm, whereas the user may
provide input through a push button, for example, and a
self-learning algorithm may correlate their activity levels or
socket tightness with the user initiated socket changes, and allow
the socket system to self-learn the user's preferences of socket
fit based on user activities, and then may perform such socket
adjustments upon learning the user's preferences via their input.
This may also correlate via number of steps, for instance the user
may typically input user preferred tightening of the socket after
about 3000 steps on average, and so the socket may automatically
tighten a comparable amount after 3000 steps, which may be driven
by sensor input and autonomous control. Likewise, when sensor input
such as an accelerometer or the like may indicate the user begins
to run, the socket may automatically tighten slightly whereas when
the user is at rest it may loosen slightly.
[0100] Since various sensors may be integrated within the system,
data collection may be captured including, but not limited to,
number of steps, timing of steps, cadence including varied cadence,
user specific activities, activity level of the user, times or use
or non-use, and socket forces, amongst others. Likewise, the
autonomous control of the socket fit may provide automatic socket
adjustments to fit, self-learning adjusting, accommodation for
volume change, user preference/learning algorithm, and others,
which may be displayed to the user.
[0101] Fitting a socket may as well include the process of forming
modular components onto the limb shape, such as but not limited to
formable struts or non-formable struts, which may be fabricated to
shape, taking an impression of the distal end of the limb to
generate a connection point between such struts and the distal
componentry, taking an impression of the proximal end the limb such
as around the `ears` of a below knee socket as needed, and fitting
such impression-created forms onto the struts for assembly of the
structural elements of a socket, and finally to assemble the other
complaint or dynamic modular components of the socket to create a
socket in its entirety. In such an example, the impressions may
include materials such as cutter-cast, fiberglass, other laminates,
thermoplastics, or similar, which may even be formed to the limb
shape in real-time, and may be used directly for the fitting,
versus using an impression to then later fabricate the same shape
from other materials. By using a real-time usable material, only
minor trim line adjustments may be needed to these structural
elements, and the socket system can be fit in real-time along with
the other dynamic socket components. Since the dynamic socket
materials may as well be modular in nature, fitting a socket in its
entirety using this method enables for the impression, fabrication,
and fitting to all take place in a single appointment without the
need of additional fabrication methods that conventional sockets
require.
[0102] Using truly conforming compliant or dynamic socket materials
as is described, along with the self-adjustable elements of the
socket shape enables the limb muscles to no longer hit a rigid
wall, as is experienced in using conventional prosthetics, and
instead promoted limb muscle use and growth, increased circulation,
and overall better limb health.
[0103] Additionally, with so many elements of the socket being
conforming, compliant, and dynamic to better contour to the limb
shape, integrating a dynamic suspension lock that moves with the
limb versus mounted to a rigid socket may additionally help provide
added comfort. Conventional socket lock mechanisms are commonly
mounted to the rigid frame structure to provide a rigid connection
point. In the disclosed socket design however, the distal
receptacle, which dynamically conforms to the limb shape, may
include a lock mechanism mounted to it, which may enable the user's
limb to connect thereto and provide a more dynamic suspension
mechanism than in conventional sockets, as the lock mechanism may
move with the limb movement within the socket.
[0104] This provides a more conforming method of suspension at the
sensitive distal end of the limb. In such an example, and as
illustrated in FIG. 26, a lock mechanism 370 may be generally
connected to the functional equivalent of a receptacle 380 as
shown, and allow the limb/liner to engage with the lock mechanism
370 in a certain location, such as illustrated in position 380. The
lock mechanism 370 may be a pin system, a lanyard system, a vacuum
or suction suspension system, or other such suspension mechanisms
known in the field. The receptacle 380 may provide conformity and
dynamic nature with the limb, but may also have enough form-factor
to hold a relative position within the socket. Too much flexibility
in the part may limit true suspension ability, while too much
rigidity may fail to accommodate for micro-movements of the limb
within the socket and put excessive pressure on the sensitive
distal end of the limb. Providing a suspension mechanism or system
that slightly moves with the limb may soften the connection point
between the sensitive limb end and the socket, providing more
comfort for the user.
[0105] Invention 10 may comprise a transfemoral prosthetic
interface having a circumference for a residual limb having a
circumference and a distal end comprising a socket having a first
side and a second side; a floating strut between said first side of
said socket and said second side wherein said floating strut does
not touch said first side or said second side of said socket; a
lacing system connected to said first side and said second said of
said socket and adapted to hold said floating strut between said
first side and said second side of said socket; and wherein said
socket, said floating strut, and said lacing system form a
circumference are adapted to support said residual limb around said
circumference of said residual limb without putting pressure on
said distal end of said limb.
[0106] Changes may be made in the combinations, operations, and
arrangements of the various parts and elements described herein
without departing from the spirit and scope of the invention.
Furthermore, names, titles, headings and general division of the
aforementioned are provided for convenience and should, therefore,
not be considered limiting.
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